NEW YORK—Pfizer Inc. announced earlier today that TRUMENBA(Meningococcal Group B Vaccine) has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years. This is the first breakthrough therapy designation for a MenB vaccine to help protect children as young as 1 year old. TRUMENBA previously received breakthrough therapy designation in 2014 for the prevention of MenB in adolescents and young adults ages 10 through 25 years, and later the same year received FDA approval as the first MenB vaccine approved in the U.S.

As noted in the 2014 breakthrough therapy approval letter, Pfizer was required to assess the safety and effectiveness of TRUMENBA in children down to 1 year of age. Pfizer has completed Phase 2 studies in this investigational age group, and the data supported Pfizer’s request for breakthrough therapy designation. The data have been submitted to the FDA.

“Despite the occurrence of invasive serogroup B disease in children ages 1 through 9 years, and the potential life-altering and long-term consequences that may result from this uncommon disease, there is no MenB vaccine licensed in the U.S. for this age group,” said Dr. Luis Jodar, Chief Medical and Scientific Affairs Officer, Vaccines Medical Development, Scientific and Clinical Affairs, Pfizer Inc. “We look forward to working closely with the FDA toward our goal to extend the range of individuals who may benefit from immunization with TRUMENBA.”

The majority of invasive meningococcal disease cases worldwide can be attributed to six Neisseria meningitidis serogroups (A, B, C, W, X, and Y). Together, serogroups A, B, C, W, and Y account for 90% of all invasive meningococcal disease, with MenB accounting for the majority of disease in adolescents and young adults in the U.S. and Europe. As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%).

In April 2017, TRUMENBA received traditional approval from the FDA in individuals 10 to 25 years of age for the three-dose schedule based on Phase 3 data, making it the only MenB vaccine in the U.S. with full approval. TRUMENBA can be administered as a two‐ or three‐dose schedule to adolescents and young adults 10 through 25 years of age, depending on an individual’s risk of exposure and susceptibility to MenB. A study to confirm the effectiveness of the two-dose schedule is ongoing.